Open-Label, Long-Term, Extension Study of Infigratinib in Children With Hypochondroplasia

This study is open to children aged between 3 and 18 years old who have Hypochondroplasia. A very important requirement is that they must have already completed a previous study called ACCEL 2/3, or in some cases, the observational ACCEL study, specifically those who had at least six months of growth monitoring in that study.

There are also some reasons why a child might not be able to join. For example, if they have another serious medical condition that could interfere with the study or make participation unsafe. Also, if they are already taking part in another medical study with a different organisation, or if they have already reached their full adult height, they would not be able to join. Girls who are 10 years or older, or any girl who has started her periods, will need to have a negative pregnancy test to make sure they are not pregnant.

If your child joins this study, they will receive the study medicine, Infigratinib, for an extended period. Since this is an extension study, the exact number and frequency of visits will be based on the established routine from the previous study your child participated in. Typically, this would involve regular clinic visits where doctors and nurses will monitor your child’s health, growth, and how the medicine is affecting them. These visits will include checks like measuring height and weight, and possibly blood tests or other assessments to keep track of their progress and safety. The total duration of participation aims to observe effects over a long period, but specific end points will be discussed with the study team.